RecruitingNot ApplicableNCT06377410

Efficacy & Safety of Dry Powder Ivy Extract (Syrup Prospan) Versus NAC Among COPD Patients

A Randomised, Open Label, Interventional Study Evaluating the Efficacy & Safety of Dry Powder Ivy Extract (Syrup Prospan) Versus NAC Among COPD Patients (SyProNAC Trial)


Sponsor

National University of Malaysia

Enrollment

100 participants

Start Date

May 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

As the third global leading cause of death, Chronic Obstructive Pulmonary Disease (COPD) affects more than 300 million people worldwide. These patients suffer from 0.5-3.5 exacerbations per year on average. Each exacerbations dampened their health status as well as quality of life, not to mention a great burden to our healthcare system. Those partially treated or prolonged exacerbations would subsequently lead to unfavorable disease progression. Hence a holistic approach in managing each exacerbations is very crucial. Mucus hypersecretion in COPD patients plays a pivotal role in acute exacerbations and associated with unfavorable outcomes. These exacerbations comes with sputum increment as much as its purulence. Mucolytics are believed to to ease patient to expectorate and benefits them from tip into an exacerbations or even the consequent hospitalisation. Mucolytics work by reducing sputum viscosity hence improved its expectoration. N-acetylcysteine (NAC) is a mucolytic with antioxidant and anti-inflammatory properties, commonly used in practice among COPD patients. Meanwhile, Syrup Prospan is ivy leaf preparations, obtained as extracts from leaves of the plant Hedera helix L. It is widely used over-the-counter cough remedy containing saponins which are believed to have expectorant properties. Studies show evidence of antispasmodic, bonchodilating, anti-inflammatory and antitussive properties and its usage is authorised by the European Medicines Agency .


Eligibility

Min Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two medications for managing mucus and breathing symptoms in people with stable COPD: a dry powder ivy leaf extract (Prospan) versus NAC (N-acetylcysteine, a common mucolytic). **You may be eligible if...** - You are 40 years or older with a confirmed diagnosis of stable COPD - Your lung function tests confirm airways obstruction (FEV1/FVC below 70% or below the lower limit of normal) - You are able to perform breathing tests (spirometry) **You may NOT be eligible if...** - You have asthma, asthma-COPD overlap, interstitial lung disease, bronchiectasis, or lung cancer - You have conditions that prevent you from safely doing breathing tests (recent heart complications, major surgery, severe respiratory disease, or neurological impairment) - You are allergic to NAC (acetylcysteine) or dry powder ivy extract - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSyrup Prospan

Participant with stable COPD who received Syrup prospan for 1 month

DRUGN-Acetylcysteine

Participant with stable COPD who received N-Acetylcysteine for 1 month


Locations(2)

National University of Malaysia, Faculty of Medicine

Cheras, Kuala Lumpur, Malaysia

National University of Malaysia

Cheras, Kuala Lumpur, Malaysia

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NCT06377410


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